FDA.reportPublic FDA data

NDC 58670-000 - Antidiarrheal LOPERAMIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58670-000
Package NDCs from labels
58670-000-10
Manufacturer
Holliday-Scott S.A. | Vasudha Pharma Chem Limited
Effective date
2013-07-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Antidiarrheal LOPERAMIDE - Holliday-Scott S.A. | Vasudha Pharma Chem LimitedHolliday-Scott S.A. | Vasudha Pharma Chem Limited2013-07-31OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58670-000-10Antidiarrheal LOPERAMIDE1 in 1 CARTONSOLUTION11
58670-000-10Antidiarrheal LOPERAMIDE10 mL in 1 BOTTLE, DROPPERSOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58670-000ANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]12 package rows20130731_273e6635-c3e6-4739-9fd0-d227c789c367.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]1
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTIDIARRHEAL LOPERAMIDE (LOPERAMIDE HYDROCHLORIDE) SOLUTION [HOLLIDAY-SCOTT S.A.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 12 · 225 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEValu Merchandisers Company33335063-49a9-4e08-9d77-4cd80e94f0212024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEFred's Inc.a3bf91ae-22f3-4402-b73c-de026f2d04752024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEChain Drug Marketing Association Inc.237b845b-0f02-410d-9750-c95123e6142d2024-01-11WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBionpharma Inc.6e60cb25-6af9-4f17-b740-a5e7b5bb2a092023-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
anti-diarrhealLOPERAMIDE HYDROCHLORIDEBionpharma Inc.a14bd404-cc79-06e0-e053-2a95a90a68412023-12-26WarningsExact identifier
unii: 77TI35393C
foster and thrive anti diarrhealLOPERAMIDE HCLStrategic Sourcing Services LLC6f70564a-4400-4ed0-960b-09135a2f3a7c2023-12-07WarningsExact identifier
unii: 77TI35393C
anti-diarrhealLOPERAMIDE HYDROCHLORIDEVALU MERCHANDISERS COMPANYfed347ad-cfbb-9ee8-e053-6394a90ad2752023-10-10WarningsExact identifier
unii: 77TI35393C
LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDEAurobindo Pharma Limited8d142533-4e87-4030-8fe9-4fc7473b04422023-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDr. Reddy's Laboratories Inc.6fe91ddc-06b6-3a51-2b48-f6f11361ab732023-06-25WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEDr. Reddy's Laboratories Inc.356d9432-d948-4b88-b297-9161b845f86b2023-06-25WarningsExact identifier
unii: 77TI35393C
Loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEViona Pharmaceuticals Inc330677ff-5426-40bd-af45-e3836cb778932023-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Loperamide hydrochlorideLOPERAMIDE HYDROCHLORIDEZydus Lifesciences Limited5d13405c-8fd7-454f-9b49-3d8b9ef672b82023-06-19Exact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEBryant Ranch Prepackf092b8a5-80b0-40ba-af45-2ac9edaa77042023-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDESTRATEGIC SOURCING SERVICESf9e03d2b-2ec0-322b-e053-6394a90a15992023-04-21WarningsExact identifier
unii: 77TI35393C
Handy Solutions Anti-DiarrhealLOPERAMIDE HYDROCHLORIDENavajo Manufacturing Company Inc.76e32e66-4af5-47a5-83ff-cbba206975d62023-03-15WarningsExact identifier
unii: 77TI35393C
Loperamide HydrochlorideLOPERAMIDE HYDROCHLORIDEallphamed Pharbil Arzneimittel GmbHa8c8d1d2-a8c7-462a-b620-729a9baa93c42023-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDETOP CARE (Topco Associates LLC)c62bc8d4-0857-16fc-e053-2a95a90a0c412022-12-30WarningsExact identifier
unii: 77TI35393C
ANTI-DIARRHEALLOPERAMIDE HYDROCHLORIDENortheast Pharmac2db4155-68d4-71be-e053-2a95a90a7f352022-12-30WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEPremier Value Alliance LLC0dd97bfb-67ce-472f-9b23-15f613bb31352022-12-29WarningsExact identifier
unii: 77TI35393C
Anti-DiarrhealLOPERAMIDE HYDROCHLORIDEWal-Mart Stores, Inc.507acd63-b2b4-465e-bb94-2d66724de20a2022-12-29WarningsExact identifier
unii: 77TI35393C

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.